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Jiangsu Well Biotech Co.,Ltd. recalls Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Recalled October 19, 2022 · FDA recall Z-0001-2023 · Jiangsu Well Biotech Co.,Ltd
Hazard
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance. · FDA Class I
Units
620,000 tests
Sold at
U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Description
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Product
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Manufacturer(s)
Jiangsu Well Biotech Co.,Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →